Crossing occlusions in blood vessels

ABSTRACT

The present disclosure is directed a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method may include providing a first intravascular device having a distal portion and at least one aperture and positioning the distal portion of the first intravascular device in the vascular wall. The method may further include providing a reentry device having a body and a distal tip, the distal tip having a natural state and a compressed state and inserting the distal tip, in the compressed state, in the distal portion of the first intravascular device. The method may further include advancing the distal tip, in the natural state, through the at least one aperture of the first intravascular device.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/063,756, filed Feb. 5, 2008, which is herein incorporated byreference in its entirety.

FIELD OF THE INVENTION

The inventions described herein relate to devices and associated methodsfor the treatment of chronic total occlusions. More particularly, theinventions described herein relate to devices and methods for crossingchronic total occlusions and establishing a pathway for blood flow pastthe chronic total occlusions.

BACKGROUND OF THE INVENTION

Due to age, high cholesterol and other contributing factors, a largepercentage of the population has arterial atherosclerosis that totallyoccludes portions of the patient's vasculature and presents significantrisks to patient health. For example, in the case of a total occlusionof a coronary artery, the result may be painful angina, loss of cardiactissue or patient death. In another example, complete occlusion of thefemoral and/or popliteal arteries in the leg may result in limbthreatening ischemia and limb amputation.

Commonly known endovascular devices and techniques are eitherinefficient (time consuming procedure), have a high risk of perforatinga vessel (poor safety) or fail to cross the occlusion (poor efficacy).Physicians currently have difficulty visualizing the native vessellumen, can not accurately direct endovascular devices toward thevisualized lumen, or fail to advance devices through the lesion. Bypasssurgery is often the preferred treatment for patients with chronic totalocclusions, but less invasive techniques would be preferred.

Described herein are devices and methods employed to exploit thevascular wall of a vascular lumen for the purpose of bypassing a totalocclusion of an artery. Exploitation of a vascular wall may involve thepassage of an endovascular device into and out of said wall which iscommonly and interchangeable described as false lumen access, intramuralaccess, submedial access or in the case of this disclosure, subintimalaccess.

SUMMARY OF THE INVENTION

Described herein are devices and methods employed to exploit thevascular wall of a vascular lumen for the purpose of bypassing a totalocclusion of an artery. Exploitation of a vascular wall may involve thepassage of an endovascular device into and out of said wall which iscommonly and interchangeable described as false lumen access, intramuralaccess, submedial access or in the case of this disclosure, subintimalaccess.

In one aspect, the present disclosure is directed a method offacilitating treatment via a vascular wall defining a vascular lumencontaining an occlusion therein. The method may include providing afirst intravascular device having a distal portion and at least oneaperture and positioning the distal portion of the first intravasculardevice in the vascular wall. The method may further include providing areentry device having a body and a distal tip, the distal tip having anatural state and a compressed state and inserting the distal tip, inthe compressed state, in the distal portion of the first intravasculardevice. The method may further include advancing the distal tip, in thenatural state, through the at least one aperture of the firstintravascular device.

In another aspect, the present disclosure is directed an apparatus forfacilitating treatment via a vascular wall defining a vascular lumencontaining an occlusion therein. The apparatus may include a firstintravascular device having a distal portion, the distal portionincluding at least one aperture, at least one radiopaque marker, and atleast one orienting element. The apparatus may further include a reentrydevice having a body and a distal tip, the distal tip having a naturalstate and a compressed state.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of an artery with a wall having threelayers. The outermost layer of the wall is the adventitia and theinnermost layer is the intima. The tissues extending between the intimaand the adventitia may be collectively referred to as the media.

FIG. 2 is an additional view of the artery shown in the previous figurein which a crossing device has been advanced over guidewire so that adistal portion of the crossing device is disposed in a proximal segmentof a true lumen of the artery.

FIG. 3 is an additional view of the artery shown in the previous figurein which the distal end of the crossing device has been advanced in adistal direction so that a tip of the crossing device is adjacent to anocclusion.

FIG. 4 is an additional view of the artery and crossing device shown inthe previous figure. In the embodiment of FIG. 4, the distal end of thecrossing device has been advanced in an axial direction past theocclusion.

FIG. 5 is a view of the artery shown in the previous figure showing thatthe crossing device has been withdrawn from the true lumen of theartery.

FIG. 6 is an additional view of the artery and the guidewire shown inthe previous figure. In the embodiment of FIG. 6, an orienting devicehas been advanced over the guidewire.

FIG. 7 is an additional view of the artery and the orienting deviceshown in the previous figure. In the embodiment of FIG. 7, the guidewirehas been withdrawn leaving the orienting device in the position shown inFIG. 7.

FIG. 8 is an additional view of the artery and the orienting deviceshown in the previous figure. In the embodiment of FIG. 8, a re-entrydevice has been advanced into the lumen of the orienting device.

FIG. 9 is an enlarged partial cross-sectional view showing a portion ofthe re-entry device and the orienting device shown in the previousfigure.

FIG. 10 is an additional partial cross-sectional view showing a portionof the re-entry device and the orienting device shown in the previousfigure.

FIG. 11 is an enlarged partial cross-sectional view showing a portion ofthe re-entry device and the orienting device shown in the previousfigure.

FIG. 12 is another enlarged partial cross-sectional view showing aportion of the re-entry device shown in the previous figure. In theembodiment of FIG. 12, a core of the re-entry device has been advancedso that a portion of the core extends beyond the body of the re-entrydevice.

FIG. 13 is an additional enlarged partial cross-sectional view showing aportion of the re-entry device shown in the previous figure. In theembodiment of FIG. 13, the re-entry device has been advanced so that apenetrator is contacting the intima of an artery.

FIG. 14 is yet another enlarged partial cross-sectional view showing aportion of the re-entry device shown in the previous figure. In theembodiment of FIG. 14, the penetrator of the re-entry device has piercedthe intima.

FIG. 15 is still another enlarged partial cross-sectional view showing aportion of the re-entry device shown in the previous figure. In theembodiment of FIG. 15, the re-entry device has been advanced so that thedistal end of the re-entry device is disposed in the true lumen of anartery.

FIG. 16 is a partial cross-sectional view of the re-entry device shownin the previous figure. FIG. 16 has a different scale than the previousfigure so that more of the surrounding context is visible in FIG. 16.

FIG. 17 is an additional view of the artery shown in the previousfigure. In the embodiment of FIG. 17, an orienting device has beenwithdrawn leaving a re-entry device in the position shown in FIG. 17.

FIG. 18 is a plan view of a crossing device in accordance with thepresent description. In the embodiment of FIG. 19, a penetrator of thecrossing device is assuming a deployed position.

FIG. 19 is an additional plan view of the re-entry device shown in theprevious figure. In the embodiment of FIG. 19, a penetrator of thecrossing device is assuming a retracted position.

FIG. 20 is a plan view of an exemplary re-entry device. Selecteddimensions of the exemplary re-entry device are illustrated in FIG. 20.

FIG. 21 and FIG. 22 illustrate a method in which a re-entry device hasbeen advanced while a core is in a retracted position. These figuresshow that the re-entry device has not penetrated intima. Instead, there-entry device has been advanced between the intima and the exterior ofthe orienting device.

FIG. 23A is a cross-sectional view of an orienting device including aradiopaque marker.

FIG. 23B is a representation of a fluoroscopic display. The radiopaquemarker of the orienting device shown in the previous figure is visiblein this fluoroscopic display. A radiopaque re-entry device is alsovisible in this display.

FIG. 24 is a plan view including the orienting device shown in theprevious figure. In FIG. 24, a distal portion of a re-entry device canbe seen extending through an aperture of the orienting device.

FIG. 25A is a cross-sectional view of an orienting device including aradiopaque marker.

FIG. 25B is a representation of a fluoroscopic display. The radiopaquemarker of the orienting device shown in the previous figure is visiblein this fluoroscopic display. A radiopaque re-entry device is alsovisible in this display.

FIG. 26 is a plan view including the orienting device shown in theprevious figure. A first balloon and a second balloon of the orientingdevice are visible in FIG. 26.

FIG. 27 is a cross sectional view of the orienting device shown in theprevious figure. A cut of the cross-sectional view is taken along lineA-A shown in FIG. 27.

FIG. 28 is a cross-sectional view of an artery with a wall having threelayers. The outermost layer of the wall is the adventitia and theinnermost layer is the intima. In FIG. 28, an orienting device is showndisposed between the adventitia and the intima.

FIG. 29 is a partial cross-sectional view of an exemplary crossingdevice comprising a tip that is fixed to a distal end of a shaft.

FIG. 30 is a plan view showing an assembly including the crossing deviceshown in the previous figure. In the embodiment of FIG. 30, a driveassembly is coupled to the shaft of the crossing device.

FIG. 31 is a cross-sectional view of the assembly shown in the previousfigure. The assembly includes a drive assembly comprising a centralgear, an internal gear and a plurality of planetary gears. These gearsform a gear train that provides a mechanical advantage.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the present embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

FIG. 1 is a cross-sectional view of an artery 20 having a wall 22. InFIG. 1, wall 22 of artery 20 is shown having three layers. The outermostlayer of wall 22 is the adventitia 24 and the innermost layer of wall 22is the intima 26. The tissues extending between intima 26 and adventitia24 may be collectively referred to as the media 28. For purposes ofillustration, intima 26, media 28 and adventitia 24 are each shown as asingle homogenous layer in FIG. 1. In the human body, however, theintima and the media each comprise a number of sub-layers. Thetransition between the external most portion of the intima and theinternal most portion of the media is sometimes referred to as thesubintimal space. Intima 26 defines a true lumen 30 of artery 20. InFIG. 1, an occlusion 36 is shown blocking true lumen 30. Occlusion 36divides true lumen 30 into a proximal segment 32 and a distal segment34. In FIG. 1, a distal portion of a guidewire 102 is shown extendinginto proximal segment 32 of true lumen 30.

As shown in FIG. 1, methods described in this document may include thestep of advancing a guidewire to a location proximate an occlusion in ablood vessel. The exemplary methods described in this document may alsoinclude the step of advancing guidewire 102 between occlusion 36 andadventitia 24. In some cases, however, the nature of the occlusion andthe blood vessel will be such that the guidewire is unlikely to advancebeyond the occlusion.

FIG. 2 is an additional view of artery 20 shown in the previous figure.In the embodiment of FIG. 2, a crossing device 104 has been advancedover guidewire 102 so that a distal portion of crossing device 104 isdisposed in proximal segment 32 of true lumen 30. Crossing device 104may be used to establish a channel between proximal segment 32 anddistal segment 34. Crossing device 104 of FIG. 2 comprises a tip 108that is fixed to a distal end of a shaft 120. As shown in FIG. 2,methods described in this document may include the step of advancing acrossing device over a guidewire.

FIG. 3 is an additional view of artery 20 shown in the previous figure.In the embodiment of FIG. 3, the distal end of crossing device 104 hasbeen advanced in a distal direction so that tip 108 is adjacent toocclusion 36. With reference to FIG. 3, it will be appreciated that tip108 has passed through intima 26 and is disposed between occlusion 36and adventitia 24 of artery 20. Some methods described in this documentmay include the step of advancing a crossing device between an occlusionand the adventitia of an artery.

FIG. 4 is an additional view of artery 20 and crossing device 104 shownin the previous figure. In the embodiment of FIG. 4, the distal end ofcrossing device 104 has been advanced in an axial direction pastocclusion 36. Accordingly, it will be appreciated that methods describedin this document may include the step of advancing a crossing devicebeyond an occlusion.

In the embodiment of FIG. 4, crossing device has crossed occlusion 36 byadvancing between occlusion 36 and adventitia 24 of artery 20. It is tobe appreciated that other methods of crossing an occlusion are withinthe spirit and scope of this disclosure. For example, the crossingdevice 104 may pass through occlusion 36 while remaining disposed insidetrue lumen 30.

In FIG. 4, tip 108 of crossing device 104 is shown residing betweenintima 26 and adventitia 24 of artery 20. As tip 108 moves in an axialdirection between intima 26 and adventitia 24, tip 108 may cause bluntdissection of the layers forming the wall of artery 20. Alternatively,tip 108 may cause blunt dissection of the materials comprising theocclusion 36.

In some useful methods in accordance with the present disclosure,crossing device 104 is rotated about its longitudinal axis and moved ina direction parallel to its longitudinal axis simultaneously. When thisis the case, rotation of crossing device 104 may reduce resistance tothe axial advancement of crossing device 104. These methods takeadvantage of the fact that the kinetic coefficient of friction isusually less than the static coefficient of friction for a givenfrictional interface. Rotating crossing device 104 assures that thecoefficient of friction at the interface between the crossing device andthe surround tissue will be a kinetic coefficient of friction and not astatic coefficient of friction.

With reference to FIG. 4, it will be appreciated that crossing device104 extends past occlusion 36. In FIG. 4, occlusion 36 is shown blockinga true lumen 30. Occlusion 36 divides true lumen 30 into a proximalsegment 32 and a distal segment 34. When a crossing device in accordancewith some embodiments of the present disclosure is advanced through thesubintimal space of an artery, the distal end of the crossing device maypenetrate the intima and enter the distal segment of the true lumenafter advancing beyond an occlusion. When this is the case, fluidcommunication between the proximal segment and the distal segment may beachieved via a channel created by the crossing device.

FIG. 5 is an additional view of artery 20 shown in the previous figure.In the embodiment of FIG. 5, crossing device 104 has been withdrawn fromtrue lumen 30 of artery 20. With reference to FIG. 5, it will beappreciated that guidewire 102 remains in the position formerly occupiedby crossing device 104.

The position of guidewire 102 shown in FIG. 5 may be achieved usingcrossing device 104. Guidewire 102 may be positioned, for example, byfirst placing crossing device 104 in the position shown in the previousfigure, then advancing guidewire 102 through lumen 122 defined by shaft120 of crossing device 104. Alternately, guidewire 102 may be disposedwithin lumen 122 while crossing device 104 is advanced beyond occlusion36.

With guidewire 102 in the position shown in FIG. 5, guidewire 102 may beused to direct other devices between occlusion 36 and adventitia 24. Forexample, a catheter may be advanced over guidewire 102 until the distalend of the catheter extends between an occlusion and the adventia. Afterreaching this location, the catheter may be used to dilate the tissuesurrounding the catheter. Examples of catheters that may be used todilate tissue include balloon catheters and atherectomy catheters.

FIG. 6 is an additional view of artery 20 and guidewire 102 shown in theprevious figure. In the embodiment of FIG. 6, an orienting device 106has been advanced over guidewire 102. Orienting device 106 includes ashaft 120 comprising a wall 124 defining a lumen 122. A first aperture126 and a second aperture 128 are also defined by wall 124. In theembodiment of FIG. 6, first aperture 126 and second aperture 128 areboth in fluid communication with lumen 122.

In the embodiment of FIG. 6, orienting device 106 has been positioned sothat first aperture 126 opens toward intima 26 of artery 20 and secondaperture 128 opens toward adventitia 24. With reference to FIG. 6, itwill be appreciated that first aperture extends in a first directionthat is represented by a first arrow AA and second aperture extends in asecond direction that is represented by a second arrow AB.

In FIG. 6, first arrow AA and second arrow AB are used to illustrate thefact that the second direction is general opposite the first direction.In the embodiment of FIG. 6, first arrow AA and second arrow AB areorient 180 degrees away from each other. In the embodiment of FIG. 6,first aperture 126 and second aperture 128 are longitudinally separatedfrom one another. Orienting device 106 includes a radiopaque marker 130that is located between first aperture 126 and second aperture 128.

FIG. 7 is an additional view of artery 20 and orienting device 106 shownin the previous figure. In the embodiment of FIG. 7, guidewire 102 hasbeen withdrawn leaving orienting device 106 in the position shown inFIG. 7. With reference to FIG. 7, it will be appreciated that orientingdevice 106 extends beyond occlusion 36. In FIG. 7, occlusion 36 is shownblocking true lumen 30. Occlusion 36 divides true lumen 30 into aproximal segment 32 and a distal segment 34. When an orienting device inaccordance with some embodiments disclosed herein is advanced betweenthe adventitia and the intima of an artery, the orienting device may beused to direct a re-entry device toward true lumen 30. Fluidcommunication between proximal segment 32 and distal segment 34 may beachieved by re-entering the true lumen with the re-entry device.

FIG. 8 is an additional view of artery 20 and orienting device 106 shownin the previous figure. In the embodiment of FIG. 8, a re-entry device100 has been advanced into lumen 122 of orienting device 106. Someuseful methods include the step of advancing the distal end of re-entrydevice 100 into true lumen 30.

FIG. 9 is an enlarged partial cross-sectional view showing a portion ofre-entry device 100 and orienting device 106 shown in the previousfigure. With reference to FIG. 9, it will be appreciated that re-entrydevice 100 includes a bend 130 near distal end 132 of re-entry device100.

FIG. 10 is an additional partial cross-sectional view showing a portionof re-entry device 100 and orienting device 106. FIG. 10 is furtherenlarged and simplified relative to the items shown in the previousfigure. In the embodiment of FIG. 10, a body 138 of re-entry device 100is biased to assume a bent shape including a bend 130. Also in theembodiment of FIG. 10, shaft 120 of orienting device 106 is holdingre-entry device 100 in a somewhat compressed state. When this is thecase, re-entry device 100 can be inserted through first aperture 126 bypositioning distal end 132 over first aperture 126 and allowing bend 130to assume it's natural state (i.e., bent at a sharper angle). Re-entrydevice 100 can be inserted through aperture 126 until it comes intocontact with intima 26.

It the embodiment of FIG. 10, distal end 132 of core 136 is axiallyaligned with first aperture 126, however, bend 130 is causing distal end132 to point away from first aperture 126. When this is the case, distalend 132 may be positioned over first aperture 126 by rotating core 136.

FIG. 11 is an enlarged partial cross-sectional view showing a portion ofre-entry device 100 and orienting device 106 shown in the previousfigure. In the embodiment of FIG. 11, re-entry device 100 has beenpositioned so that a distal portion of re-entry device 100 has enteredfirst aperture 126. Intima 26 is shown below first aperture 126 in FIG.11.

FIG. 12 is an enlarged partial cross-sectional view showing a portion ofre-entry device 100 and intima 26. With reference to FIG. 12, it will beappreciated that re-entry device 100 comprises a body 138 and a core136. In the embodiment of FIG. 12, core 136 has been advanced so that aportion of core 136 extends beyond body 138. For purposes ofillustration and exposition, the portion of core 136 extending beyondbody 138 is referred to as a penetrator 140. Embodiments of re-entrydevice 100 are contemplated in which penetrator 140 is fixed in theposition shown in FIG. 12.

FIG. 13 is an enlarged partial cross-sectional view showing a portion ofre-entry device 100. In the embodiment of FIG. 13, re-entry device 100has been advanced so that penetrator 140 is shown contacting intima 26in FIG. 13.

FIG. 14 is an enlarged partial cross-sectional view showing a portion ofre-entry device 100. In the embodiment of FIG. 14, penetrator 140 ofre-entry device 100 has pierced intima 26.

FIG. 15 is an enlarged partial cross-sectional view showing a portion ofre-entry device 100. In the embodiment of FIG. 15, re-entry device 100has been advanced so that distal end 132 of re-entry device 100 isdisposed in true lumen 30.

FIG. 16 is a partial cross-sectional view of re-entry device 100 shownin the previous figure. FIG. 16 has a different scale than the previousfigure so that more of the surrounding context is visible in FIG. 16. InFIG. 16, distal end 132 of re-entry device 100 can be seen residing intrue lumen 30.

FIG. 17 is an additional view of artery 20 shown in the previous figure.In the embodiment of FIG. 17, orienting device 106 has been withdrawnleaving re-entry device 100 in the position shown in FIG. 17. Devicessuch as balloon angioplasty catheters and atherectomy catheters may beadvanced over re-entry device 100. In this way, these devices may beused in conjunction with re-entry device 100 to establish a blood flowpath between proximal segment 32 of true lumen 30 and distal segment 34of true lumen 30. This path allows blood to flow around occlusion 36.

FIG. 18 is a plan view of a re-entry device 100 in accordance with thepresent description. Crossing device 104 includes an elongate body 138having a distal end 132 and a proximal end 134. In the embodiment ofFIG. 18, a core 136 extends into a lumen 122 defined by body 138. Insome useful embodiments, core 136 is free to advance and retractrelative to body 138. When core 136 is moved relative to body 138,penetrator 140 can be caused to selectively assume the retractedposition and/or the deployed position. In FIG. 18, penetrator 140 isshown in the deployed position.

In the embodiment of FIG. 18, an actuating fixture 142 is fixed to body138 near proximal end 134. Also in FIG. 18, a pushing force is shownacting on a proximal portion of core 136. This pushing force isrepresented by an arrow PF in FIG. 18. Actuating fixture 142 may be usedwhen creating relative motion between core 136 and body 138. Actuatingfixture 142 may be held to hold body 138 relatively stationary andpushing/pulling forces may be applied to core 136 to move core 136relative to body 138. In FIG. 18, body 138 of re-entry device 100 isshown being bent at an angle A. Accordingly, it can be said thatre-entry device 100 includes a bend 130. In some useful embodiments ofre-entry device 100, angle A is between about 120 degrees and about 150degrees.

FIG. 19 is an additional plan view of re-entry device 100 shown in theprevious figure. In the embodiment of FIG. 19, penetrator 140 isassuming a retracted position. A pulling force applied to core 136 whileholding actuating fixture 142 relatively stationary may cause penetrator140 to assume the retracted position.

With reference to the figures, it will be appreciated that whenpenetrator 140 is in the retracted position, the distal portion ofre-entry device 100 has a less traumatic shape than when penetrator 140is in the deployed position. Conversely, when penetrator 140 is in thedeployed position, the distal portion of re-entry device 100 has a moretraumatic shape than when penetrator 140 is in the retracted position.

The position of core 136 may be changed relative to body 138 by applypushing and/or pulling forces on core 136 and body 138. In FIG. 19, apulling force is represented with an arrow UF. A physician may utilizethis mechanism to selectively alter the overall shape of a distalportion of re-entry device 100. Changes in the shape of the distalportion of re-entry device 100 may assist in re-entry through theintima.

FIG. 20 is a plan view of a re-entry device 100 illustrating selecteddimensions of re-entry device 100. In the embodiment of FIG. 20, apenetrator 140 of core 136 extends beyond a distal end 132 of body 138by a distance L1. In the embodiment of FIG. 20, penetrator 140 has adiameter D1 and body 138 has a diameter D2. With reference to FIG. 20,it will be appreciated that diameter D2 of body 138 is greater thandiameter D1 of penetrator 140.

With reference to FIG. 20, it will be appreciated that body 138 ofre-entry device 100 includes a bend 130 near its distal end 132. Body138 has a distal leg 144 disposed distally of bend 130 and a proximalleg 146 disposed proximally of bend 130. As shown in FIG. 20, distal leg144 has a length of L2. With reference to FIG. 20, it will beappreciated that length L2 is greater than distance L1.

In some useful embodiments, diameter D1 of penetrator 140 is betweenabout 0.0020 inches and about 0.0055 inches.

In some useful embodiments, diameter D2 of body 138 is between about0.008 inches and about 0.015 inches.

In some useful embodiments, length L1 of penetrator 140 is between about0.003 inches and about 0.012 inches.

In some useful embodiments, length L2 of distal leg 144 is between about0.040 inches and about 0.080 inches.

FIG. 21 and FIG. 22 illustrate a method in which re-entry device 100 hasbeen advanced while core 136 is in a retracted position. With referenceto the figures, it will be appreciated that re-entry device 100 has notpenetrated intima 26. Instead, re-entry device has been advanced betweenintima 26 and the exterior of orienting device 106.

FIG. 23A is a cross-sectional view of an orienting device 106. Orientingdevice 106 includes a shaft 120 comprising a wall 124 defining a lumen122. Wall 124 defines a first aperture 126 and a second aperture 128that are both in fluid communication with lumen 122. In the embodimentof FIG. 23A, first aperture 126 extends away from lumen 122 in a firstdirection that is represented by a first arrow AA in FIG. 23A. Secondaperture 128 extends away from lumen 122 in a second direction that isrepresented by a second arrow AB in FIG. 23A. In FIG. 23A, first arrowAA and second arrow AB extend in generally opposite directions.Accordingly, the first direction is about 180 degrees from the seconddirection.

In the embodiment of FIG. 23A, first aperture 126 and second aperture128 are longitudinally separated from one another. Orienting device 106includes a first radiopaque marker 130A that is located between firstaperture 126 and second aperture 128. A second radiopaque marker 130B oforienting device 106 is located distally of second aperture 128.

A re-entry device 100 is disposed in lumen 122 of orienting device 106.In the embodiment of FIG. 25A, first radiopaque marker 130A, secondradiopaque marker 130B and re-entry device 100 comprise radiopaquematerials. Because of the radiopaque nature of their materials ofconstruction, first radiopaque marker 130A, second radiopaque marker130B, and re-entry device 100 will all be visible on a fluoroscopicdisplay during a fluoroscopic procedure.

FIG. 23B is a representation of a fluoroscopic display 148. Firstradiopaque marker 130A, second radiopaque marker 130B, and re-entrydevice 100 are visible in fluoroscopic display 148. In the embodiment ofFIG. 23B, distal end 132 of re-entry device 100 is located slightlyproximal of first radiopaque marker 130A. Accordingly, re-entry device100 is seen extending across fluoroscopic display 148 and ending justshort of first radiopaque marker 130A. When a physician views display148 shown in FIG. 23B, the physician may infer that distal end 132 isproximate first aperture 126 of orienting device 106. After determiningthat distal end 132 of re-entry device 100 is in this location, thephysician can rotate re-entry device 100 until distal end 132 entersinto first aperture 126.

FIG. 24 is a plan view including orienting device 106 shown in theprevious figure. In FIG. 24, a distal portion of re-entry device 100 canbe seen extending through first aperture 126. First aperture 126 andsecond aperture 128 both fluidly communicate with lumen 122 of orientingdevice 106. Orienting device 106 includes a first radiopaque marker 130Athat is located between first aperture 126 and second aperture 128. Asecond radiopaque marker 130B of orienting device 106 is locateddistally of second aperture 128.

Orienting device 106 comprises an elongate shaft 120, a first orientingelement 150, and second orienting element (not visible in FIG. 24).First orienting element 150 comprises a first balloon 152 and secondorienting element comprises a second balloon. When these balloons areinflated between the adventitia and the intima of a blood vessel,orienting device 106 will orient itself within the blood vessel so thateither first aperture 126 or second aperture 128 will open toward a truelumen of the artery. The physician may select the aperture openingtoward the true lumen using methods described herein. The physician maythen use methods in accordance with this disclosure to insert distal end132 of re-entry device 100 through the selected aperture.

FIG. 25A is a cross-sectional view of an orienting device 106. Orientingdevice 106 includes a shaft 120 comprising a wall 124 defining a lumen122. In the embodiment of FIG. 25, a re-entry device 100 is disposed inlumen 122. Wall 124 defines a first aperture 126 and a second aperture128 that are both in fluid communication with lumen 122.

In the embodiment of FIG. 25A, first aperture 126 and second aperture128 are longitudinally separated from one another. Orienting device 106includes a first radiopaque marker 130A that is located between firstaperture 126 and second aperture 128. Orienting device 106 alsocomprises a second radiopaque marker 130B that is located distally ofsecond aperture 128. With reference to FIG. 25A, it will be appreciatedthat first radiopaque marker 130A and second radiopaque maker 130B areboth surrounded by wall 124 of shaft 120.

In the embodiment of FIG. 25A, first radiopaque marker 130A, secondradiopaque marker 130B and re-entry device 100 comprise radiopaquematerials. Because of the radiopaque nature of their materials ofconstruction, first radiopaque marker 130A, second radiopaque marker130B, and re-entry device 100 will all be visible on a fluoroscopicdisplay during a fluoroscopic procedure.

FIG. 25B is a representation of a fluoroscopic display 148. Firstradiopaque marker 130A, second radiopaque marker 130B, and re-entrydevice 100 are visible in fluoroscopic display 148. In the embodiment ofFIG. 25B, distal end 132 of re-entry device 100 is located slightlyproximal of second radiopaque marker 130B. Accordingly, re-entry device100 is seen extending across fluoroscopic display 148 and ending justshort of second radiopaque marker 130B. When a physician views display148 shown in FIG. 25B, the physician may infer that distal end 132 isproximate second aperture 126 of orienting device 106. After determiningthat distal end 132 of re-entry device 100 is in this location, thephysician can rotate re-entry device 100 until distal end 132 entersinto second aperture 126.

FIG. 26 is a plan view including orienting device 106 shown in theprevious figure. Orienting device 106 comprises an elongate shaft 120, afirst balloon 152, and a second balloon 154. In the embodiment of FIG.26, first balloon 152 and second balloon 154 are both formed fromextruded portions of an outer wall 124 of elongate shaft 120. Outer wall124 defines a second aperture 128. In FIG. 26, a re-entry device 100 isshown extending through second aperture 128.

FIG. 27 is a cross sectional view of orienting device 106 taken alongline A-A shown in FIG. 26. With reference to FIG. 27, it will beappreciated that elongate shaft 120 defines a lumen 122A, a firstplanetary lumen 122B, and a second planetary lumen 122C. The planetarylumens are defined in part by an outer wall 124 of elongate shaft 120.Outer wall 124 defines a first aperture 126 and a second aperture 128.

In the embodiment of FIG. 27, a first balloon 152 is formed of anextruded portion of outer wall 124 of elongate shaft 120. First balloon152 defines an interior that is in fluid communication with firstplanetary lumen 122B. In the embodiment of FIG. 27, first balloon 152and elongate shaft 120 are monolithic. As shown in FIG. 27, firstballoon 152 and outer wall 124 of elongate shaft 120 are seamlesslyformed from a single piece of material. With reference to FIG. 27, itwill be appreciated that second balloon 154 defines an interior that isin fluid communication with second planetary lumen 122C. In theembodiment of FIG. 27, second balloon 154 comprises an extruded portionof outer wall 124 of elongate shaft 120.

As shown in FIG. 27, second balloon 154 and elongate shaft 120 areseamlessly formed from a single piece of material. Second balloon 154may be formed, for example, by extruding a portion of outer wall 124. Insome useful embodiments, elongate shaft 120 comprises a thermoplasticmaterial. When this is the case, elongate shaft 120 may be formed, forexample, using an extrusion process. Also when this is the case, firstballoon 152 and second balloon 154 may be formed by further extrudingouter wall 124 of elongate shaft 120.

FIG. 28 is a cross-sectional view of an artery 20 having a wall 22. InFIG. 28, wall 22 of artery 20 is shown having three layers. Theoutermost layer of wall 22 is the adventitia 24 and the innermost layerof wall 22 is the intima 26. The tissues extending between intima 26 andadventitia 24 may be collectively referred to as the media 28. Forpurposes of illustration, intima 26, media 28 and adventitia 24 are eachshown as a single homogenous layer in FIG. 28. In the human body,however, the intima and the media each comprise a number of sub-layers.The transition between the external most portion of the intima and theinternal most portion of the media is sometimes referred to as thesubintimal space. Intima 26 defines a true lumen 30 of artery 20.

In FIG. 28, orienting device 106 is shown disposed between adventitia 24and intima 26 of artery 20. Orienting device 106 may be used to direct are-entry device 100 toward true lumen 30 of artery 20 as shown in FIG.28. The first aperture 126 and second aperture 128 are generallyoriented at a right angle to a plane defined by first balloon 152 andsecond balloon 154. With this arrangement, each aperture is eitherdirected toward true lumen 30 of artery 20 or 180 degrees away from truelumen 30 when first balloon 152 and second balloon 154 are inflated. Inthis way, orienting device 106 reduces the number of directions anaperture may be facing from 360 degrees of freedom to two degrees offreedom, 180 degrees apart.

FIG. 29 is a partial cross-sectional view of an exemplary crossingdevice 104. Crossing device 104 of FIG. 29 comprises a tip 108 that isfixed to a distal end of a shaft 120. In the exemplary embodiment ofFIG. 29, shaft 120 comprises a coil 156, a sleeve 158, a tubular body160, and a sheath 162.

Tip 108 is fixed to a distal portion of coil 156. Coil 156 comprises aplurality of filars that are wound in a generally helical shape. In someuseful embodiments of crossing device 104, coil 156 comprises eight,nine or ten filars wound into the shape illustrated in FIG. 29. Crossingdevice 104 includes a sleeve 158 that is disposed about a portion ofcoil 156. Sleeve 158 may comprise, for example, PET shrink tubing, i.e.polyethylene terephthalate.

Sleeve 158 and coil 156 both extend into a lumen defined by a tubularbody 160. Tubular body 160 may comprise, for example hypodermic tubingformed of Nitnol, i.e. nickel titanium. With reference to FIG. 29, itwill be appreciated that a proximal portion of sleeve 158 is disposedbetween tubular body 160 and coil 156. In some embodiments of crossingdevice 104, a distal portion of tubular body 160 defines a helical cut.This helical cut may be formed, for example, using a laser cuttingprocess. The helical cut may be shaped and dimensioned to provide anadvantageous transition in lateral stiffness proximate the distal end oftubular body 160.

A proximal portion of coil 156 extends proximally beyond the distal endof tubular body 160. A hub is fixed to a proximal portion of coil 156and a proximal portion of tubular body 160. The hub may comprise, forexample, a luer fitting. A sheath 162 is disposed about a portion oftubular body 160 and a portion of sleeve 158. In some embodiments ofcrossing device 104, sheath 162 comprises HYTREL, a thermoplasticelastomer.

With reference to FIG. 29, it will be appreciated that tubular body 160,coil 156, sleeve 158, and sheath 162 each have a proximal end and adistal end. The proximal end of outer sleeve 158 is disposed between theproximal end of tubular body 160 and the proximal end of sleeve 158. Thedistal end of sleeve 158 is positioned proximate tip 108 that is fixedto the distal end of coil 156. The distal end of sheath 162 is locatedbetween the distal end of tubular body 160 and the distal end of sleeve158. With reference to FIG. 29, it will be appreciated that sheath 162overlays the distal end of tubular body 160.

With reference to FIG. 29, it will be appreciate that tip 108 has agenerally rounded shape. The generally rounded shape of tip 108 mayreduce the likelihood that crossing device 104 will penetrate theadventitia of an artery. Tip 108 may be formed from a suitable metallicmaterial including but not limited to stainless steel, silver solder,and braze. Tip 108 may also be formed from suitable polymeric materialsor adhesives including but not limited to polycarbonate, polyethyleneand epoxy. In some embodiments of crossing device 104, the outer surfaceof tip 108 comprises a generally non-abrasive surface. For example, theouter surface of tip 108 may have a surface roughness of about 25micrometers or less. A tip member having a relatively smooth outersurface may reduce the likelihood that the tip member will abrade theadventitia of an artery.

FIG. 30 is a plan view showing an assembly 164 including crossing device104 shown in the previous figure. In the embodiment of FIG. 30, a driveassembly 166 is coupled to crossing device 104. In FIG. 30, driveassembly 166 is shown disposed about a proximal portion of shaft 120 ofcrossing device 104. Drive assembly 166 comprises a handle body 172 andan anchor 168.

As shown in FIG. 30, handle body 172 of drive assembly 166 is longenough to receive the thumb and forefingers of a right hand RH and aleft hand LH. Anchor 168 of drive assembly 166 defines a hole 170. Withreference to FIG. 30, it will be appreciated that a finger F of righthand RH is extending through hole 170 in anchor 168. Left hand LH andright hand RH may rotate handle body 172 of drive assembly 166. Whenthis is the case, finger F extending through anchor 168 prevents anchor168 from rotating while handle body 172 rotates.

In FIG. 30, a distal portion of handle body 172 is positioned betweenthe thumb and forefinger of a left hand LH. A proximal portion of handlebody 172 is disposed between the thumb and forefinger of a right handRH. In some useful methods, crossing device 104 is rotated and axiallyadvanced simultaneously. Rotation of crossing device 104 can be achievedby rolling handle body 172 between the thumb and forefinger one hand.Two hands can also be used as shown in FIG. 30. Rotating crossing device104 assures that the coefficient of friction at the interface betweenthe crossing device and the surrounding tissue will be a kineticcoefficient of friction and not a static coefficient of friction.

FIG. 31 is a cross-sectional view of assembly 164 shown in the previousfigure. Assembly 164 includes a drive assembly 166 and a crossing device104. With reference to FIG. 31, it will be appreciated that driveassembly 166 includes a central gear 202 that is fixed to shaft 120 ofcrossing device 104. Drive assembly 166 also includes a handle body 172.An internal gear 206 is fixed to handle body 172.

A plurality of planetary gears 204 are disposed between central gear202. A ring 174 maintains the spacing between adjacent pairs planetarygears 204. Anchor 168 is fixed to ring 174. Anchor 168 defines a hole170. Central gear 202, planetary gears 204, and internal gear 206together form a gear train providing a mechanical advantage. Due to thismechanical advantage, a single rotation of handle body 172 results inmany rotations of shaft 120 of crossing device 104.

In some useful methods in accordance with the present disclosure,crossing device 104 is rotated at a rotational speed of between about 2revolutions per minute and about 200 revolutions per minute. In someparticularly useful methods in accordance with the present disclosure,crossing device 104 is rotated at a rotational speed of between about 50revolutions per minute and about 150 revolutions per minute. Crossingdevice 104 may be rotated by hand as depicted in the previous figure. Itis also contemplated that a mechanical device (e.g., an electric motor)may be used to rotate crossing device 104.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. A method of facilitating treatment via a vascular wall defining avascular lumen containing an occlusion therein, the method comprising:positioning a distal portion of a first intravascular device in thevascular wall, the first intravascular device including a firstaperture, a second aperture, a first radiopaque marker, and a secondradiopaque marker, the first aperture being longitudinally offset fromthe second aperture with the first aperture located proximal the secondaperture, the first radiopaque marker being located between the firstaperture and the second aperture, the second radiopaque marker beinglocated distal the second aperture; inserting a distal end of a reentrydevice, in a compressed state, in the distal portion of the firstintravascular device; positioning the distal end of the reentry deviceproximal the first radiopaque marker of the first intravascular device;rotating the reentry device until the distal end of the reentry device,in a natural state, enters the first aperture of the first intravasculardevice; positioning the distal end of the reentry device proximal thesecond radiopaque marker of the first intravascular device and distalthe first radiopaque marker of the first intravascular device; rotatingthe reentry device until the distal end of the reentry device, in thenatural state, enters the second aperture of the first intravasculardevice; and advancing the distal end, in a natural state, through thesecond aperture of the first intravascular device.
 2. The method ofclaim 1, wherein when the distal end is in the natural state, the distalend forms an angle with a body of the reentry device.
 3. The method ofclaim 2, wherein the angle is between about 120 degrees and about 150degrees.
 4. The method of claim 1, further including directing thedistal end of the reentry device towards the vascular lumen and intocontact with an intimal layer of the vascular wall.
 5. The method ofclaim 1, wherein the reentry device includes a body, the body defining adevice lumen, and a core located in the device lumen that is movablerelative to the device lumen.
 6. The method of claim 5, furtherincluding moving a distal tip of the core of the reentry device beyondthe distal end of the reentry device.
 7. The method of claim 5, furthercomprising piercing an intimal layer of the vascular wall with thereentry device, and advancing the distal end of the reentry device intothe vascular lumen.
 8. The method of claim 7, wherein the core includesa penetrator, and wherein the penetrator is configured to pierce anintimal layer of the vascular wall before the distal end of the reentrydevice is advanced into the vascular lumen.
 9. The method of claim 1,further including: positioning a second intravascular device in thevascular wall prior to positioning the distal portion of the firstintravascular device in the vascular wall; and advancing a distalportion of the second intravascular device in the vascular wall beyondthe occlusion.
 10. The method of claim 9, further including advancing aguidewire through a lumen of the second intravascular device, andremoving the second intravascular device from the vascular wall whileleaving the guidewire in the vascular wall.
 11. The method of claim 10,wherein positioning the distal portion of the first intravascular devicein the vascular wall comprises advancing the first intravascular deviceover the guidewire.
 12. The method of claim 11, further comprisingwithdrawing the guidewire from a guidewire lumen of the firstintravascular device.
 13. The method of claim 12, further comprisingadvancing at least a portion of the reentry device into the guidewirelumen of the first intravascular device.
 14. The method of claim 13,further comprising removing the first intravascular device from thevascular wall while a distal portion of the reentry device is extendingthrough an intimal portion of the vascular wall.
 15. The method of claim14, further comprising advancing a therapy catheter over the reentrydevice.
 16. A method of facilitating treatment via a vascular walldefining a vascular lumen containing an occlusion therein, the methodcomprising: positioning a distal portion of a first intravascular devicein the vascular wall; inserting a distal end of a reentry device in thedistal portion of the first intravascular device, the reentry deviceincluding a penetrator that extends distally beyond a distal surface ofa body of the reentry device; positioning the distal end of the reentrydevice proximate a first aperture of the first intravascular device;rotating the reentry device until the distal end of the reentry deviceenters the first aperture of the first intravascular device; positioningthe distal end of the reentry device proximate a second aperture of thefirst intravascular device; rotating the reentry device until the distalend of the reentry device enters the second aperture of the firstintravascular device; and advancing the penetrator through the secondaperture of the first intravascular device.
 17. The method of claim 16,further comprising contacting an intimal layer of the vascular wall withthe penetrator.
 18. The method of claim 17, further comprisingcontacting the intimal layer of the vascular wall with the distal end.19. The method of claim 18, wherein the penetrator contacts the intimallayer of the vascular wall before the distal surface of the body of thereentry device contacts the intimal layer of the vascular wall.
 20. Themethod of claim 16, further comprising piercing the intimal layer of thevascular wall with the penetrator.
 21. The method of claim 20, furthercomprising piercing the intimal layer of the vascular wall with thedistal end.
 22. The method of claim 21, wherein the penetrator piercesthe intimal layer of the vascular wall before the distal surface of thebody pierces the intimal layer of the vascular wall.
 23. The method ofclaim 16, wherein the reentry device has a core including thepenetrator, the core being movable relative to the body of the reentrydevice, and further including moving the core relative to the body. 24.The method of claim 23, wherein moving the core relative to the bodycomprises moving a distal end of the core beyond the distal surface ofthe body.
 25. The method of claim 16, wherein the penetrator is fixedrelative to the body.
 26. The method of claim 16, further comprisingadvancing the distal end of the reentry device into the vascular lumen.27. The method of claim 16, wherein the first intravascular deviceincludes a second aperture.
 28. The method of claim 27, wherein thefirst aperture is located proximal the second aperture.
 29. The methodof claim 16, further including determining whether the distal end of thereenty device is directed toward the vascular lumen or directed awayfrom the vascular lumen, wherein determining whether the distal end ofthe reentry device is directed toward the vascular lumen or directedaway from the vascular lumen comprises viewing the distal end of thereentry device using fluoroscopy.
 30. The method of claim 29, furthercomprising advancing the distal end tip of the reentry device through anintimal portion of the vascular wall if it is determined that the distalend tip of the reentry device is directed toward the vascular lumen. 31.The method of claim 29, further comprising advancing the distal end tipof the reentry device into the vascular lumen if it is determined thatthe distal end tip of the reentry device is directed toward the vascularlumen.
 32. The method of claim 29, further comprising withdrawing thedistal end tip of the reentry device into the first intravascular deviceif it is determined that the distal end tip of the reentry device isdirected away from the vascular lumen.
 33. The method of claim 16,further comprising withdrawing one of a guidewire and the reentry devicefrom a guidewire lumen of the first intravascular device and advancingthe other of the guidewire and the reentry device into the guidewirelumen of the first intravascular device.
 34. The method of claim 1,further including determining whether the distal end of the reentydevice is directed toward the vascular lumen or directed away from thevascular lumen, wherein determining whether the distal end of thereentry device is directed toward the vascular lumen or directed awayfrom the vascular lumen comprises viewing the distal end of the reentrydevice using fluoroscopy.
 35. The method of claim 1, further comprisingadvancing the distal end of the reentry device through an intimalportion of the vascular wall if it is determined that the distal end ofthe reentry device is directed toward the vascular lumen.
 36. The methodof claim 1, further comprising advancing the distal end of the reentrydevice into the vascular lumen if it is determined that the distal endof the reentry device is directed toward the vascular lumen.
 37. Themethod of claim 1, further comprising withdrawing the distal end of thereentry device into the first intravascular device if it is determinedthat the distal end of the reentry device is directed away from thevascular lumen.
 38. The method of claim 1, further comprisingdetermining whether the distal end of the reentry device, advancedthrough the other of the first aperture and the second aperture, isdirected toward the vascular lumen or directed away from the vascularlumen.
 39. The method of claim 1, further comprising withdrawing one ofa guidewire and the reentry device from a guidewire lumen of the firstintravascular device and advancing the other of the guidewire and thereentry device into the guidewire lumen of the first intravasculardevice.
 40. A method of facilitating treatment via a vascular walldefining a vascular lumen containing an occlusion therein, the methodcomprising: positioning a distal portion of a first intravascular devicein the vascular wall; inserting a distal end of a reentry device in thedistal portion of the first intravascular device; positioning the distalend of the reentry device proximate a first aperture of the firstintravascular device; rotating the reentry device until the distal endof the reentry device enters the first aperture of the firstintravascular device; positioning the distal end of the reentry deviceproximate a second aperture of the first intravascular; rotating thereentry device until the distal end of the reentry device enters thesecond aperture of the first intravascular device; and advancing thedistal end through the second aperture of the first intravasculardevice.
 41. The method of claim 40, wherein the distal end has a naturalstate such that when the distal end is in the natural state, the distalend forms an angle with a body of the reentry device.
 42. The method ofclaim 41, wherein the angle is between about 120 degrees and about 150degrees.
 43. The method of claim 40, further including directing thedistal end of the reentry device towards the vascular lumen and intocontact with an intimal layer of the vascular wall.
 44. The method ofclaim 40, wherein the reentry device includes a body, the body defininga device lumen.
 45. The method of claim 44, further comprising piercingan intimal layer of the vascular wall with the reentry device, andadvancing the distal end of the reentry device into the vascular lumen.46. The method of claim 45, wherein the reentry device includes apenetrator, and wherein the penetrator is configured to pierce theintimal layer of the vascular wall before the distal end of the reentrydevice is advanced into the vascular lumen.
 47. The method of claim 40,further comprising advancing the distal end of the reentry device intothe vascular lumen if it is determined that the distal end of thereentry device is directed toward the vascular lumen.
 48. The method ofclaim 40, further comprising withdrawing the distal end of the reentrydevice into the first intravascular device if it is determined that thedistal end of the reentry device is directed away from the vascularlumen.
 49. The method of claim 40, further comprising withdrawing one ofa guidewire and the reentry device from a guidewire lumen of the firstintravascular device and advancing the other of the guidewire and thereentry device into the guidewire lumen of the first intravasculardevice.
 50. The method of claim 40, further including: positioning asecond intravascular device in the vascular wall prior to positioningthe distal portion of the first intravascular device in the vascularwall; and advancing a distal portion of the second intravascular devicein the vascular wall beyond the occlusion.
 51. The method of claim 50,further including advancing a guidewire through a lumen of the secondintravascular device, and removing the second intravascular device fromthe vascular wall while leaving the guidewire in the vascular wall. 52.The method of claim 40, wherein the first intravascular device includesa first radiopaque marker and a second radiopaque marker, the firstaperture being longitudinally offset from the second aperture with thefirst aperture located proximal the second aperture, the firstradiopaque marker being located between the first aperture and thesecond aperture, the second radiopaque marker being located distal thesecond aperture.
 53. The method of claim 40, further including apenetrator located at a distal tip of the distal end.